Planmeca
Unités dentaires, systèmes d'imagerie, systèmes CAD/CAM et instruments dentaires.
Planmeca fabrique des unités dentaires, des systèmes d'imagerie, des systèmes CAD/CAM et des instruments dentaires depuis ses sites d'Helsinki. La société fournit des acheteurs d'hôpitaux, des distributeurs cliniques, des systèmes de santé ou des clients exportateurs sur ses principaux marchés cotés.
- Type
- brand seeking distribution
- Location
- Helsinki, Finland
- Founded
- 1971
- Website
- planmeca.com
- Categories
- Fournitures médicales et de santé, Fournitures industrielles, Fournitures et équipements dentaires
- Markets
- Finlande, Allemagne, États-Unis, Japon
Verified facts
- certificate-page-on-site (amber), checked 2026-08-11 Company's own certification page
- standards-mark-certified (green), checked 2026-08-16 EAEU unified register of certificates and declarations
- registry-activity (green), checked 2026-07-09 Finnish Patent and Registration Office (PRH)
- domain-registered (green), checked 2026-08-02 Domain registry record
- lei-active (green), checked 2026-08-23 GLEIF global LEI register (golden copy)
- registry-active-global (green), checked 2026-07-09 Finnish Patent and Registration Office (PRH)
Claimed certifications
- ISO 13485, Medical Devices Quality IAF CertSearch
- CE Marking EU NANDO (notified bodies)
- EAC mark (EAEU conformity) EAEU unified register of certificates and declarations
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)